Respironics System One Heated Humidifier User manual

Respironics
Brand
Respironics
Model
System One Heated Humidifier
Category
Humidifiers
Type
User manual
System One
Heated Humidier
USER MANUAL
© 2009 Respironics Inc. and its afliates. All rights reserved.
1
Table of Contents
Intended Use ........................................................................................................................................................... 2
Warnings .................................................................................................................................................................. 2
Cautions ................................................................................................................................................................... 2
Symbol Key .............................................................................................................................................................. 2
System Features and Contents ...........................................................................................................................3
Connecting the Therapy Device ......................................................................................................................... 4
Disconnecting the Therapy Device .................................................................................................................... 5
Daily Use..................................................................................................................................................................5
Home Cleaning: Water Tank ............................................................................................................................... 9
Home Cleaning: Humidier Base ....................................................................................................................... 9
Hospital and Institution Cleaning .....................................................................................................................10
Service ....................................................................................................................................................................10
Traveling with the System ..................................................................................................................................10
Troubleshooting ...................................................................................................................................................11
Specications ........................................................................................................................................................13
Disposal ..................................................................................................................................................................14
How to Contact Respironics ............................................................................................................................14
EMC Information .................................................................................................................................................15
Limited Warranty ...................................................................................................................................Back Page
2
CAUTION: U. S. federal law restricts this device to sale by or on the order of a physician.
Intended Use
The Heated Humidier is an accessory for the Respironics REMstar and BiPAP therapy devices to provide moisture
to the patient circuit. It is intended for use in spontaneously breathing patients weighing over 30 kg (66 lbs), in the
home or hospital/institutional environment, who use mask-applied positive pressure ventilation therapy.
Warnings
A warning indicates the possibility for injury to the user or the operator.
• Use the humidier only for its intended use as described in this manual. Use only accessories recommended by Respironics.
• Periodically inspect the humidier for signs of wear or damage. Never operate the humidier if any parts are damaged, if it is not
working properly, or if the humidier has been dropped or mishandled. Do not use the humidier if the water tank is leaking or
damaged in any way. Have any damaged parts replaced before continuing use.
• Periodically inspect the humidier power cord for signs of wear or damage. If it becomes worn or damaged, contact Respironics
or your home care provider for a replacement.
• Allow the humidier heater plate and water to cool down for approximately 15 minutes before removing the water tank. A burn
may result from: touching the heater plate, coming in contact with the heated water, or touching the tank pan.
• This equipment is not suitable for use in the presence of a ammable anesthetic mixture with air or with oxygen or nitrous oxide.
• When installing the water tank, do not allow any water to spill into the humidier or therapy device.
• If you notice any unexplained changes in the performance of this device, if it is making unusual or harsh sounds, if it has been
dropped or mishandled, if water is spilled into the enclosure, or if the enclosure is broken, disconnect the power cord from the
therapy device and discontinue use. Contact your home care provider.
• Before cleaning the humidier, always remove from the therapy device.
• Empty and clean the water tank daily to prevent mold and bacteria growth. Wipe the seal completely.
Note: Please see the “Limited Warranty” section of this manual for information on warranty coverage.
Cautions
A caution indicates the possibility of damage to the device.
• Do not place the humidier directly onto carpet, fabric, or other ammable materials.
• Do not place the device in or on any container that can collect or hold water. Take precautions to protect furniture from water damage.
• Do not ll the water tank above the maximum ll line. Damage to the humidier or therapy device may occur. If the water tank is
overlled, water may leak out of the tank inlet (located on the back of the tank) when installing the tank lid.
• Use only room temperature distilled water in the tank. Do not put any chemicals or additives into the water. Possible airway
irritation or damage to the water tank may result.
• Remove the tank, empty all water, and replace the empty tank before transporting the humidifier base.
• Do not attempt to ll the water tank while it is still inside the humidier.
• To avoid spilling, do not disconnect the humidier from the therapy device with water in the tank. Remove the water tank from
the humidier before disconnecting the therapy device.
• Do not turn the humidier on without the water tank installed. The Humidier number setting must remain on 0 if there is no
water in the water tank.
• The humidier door must be set in the open position before removing the water tank. Do not remove the water tank without
making sure that the humidier door locks into the open position.
• Do not move the humidier while the water tank has water in it.
• Only the hospital and institution cleaning procedures listed in this manual are recommended by Respironics. Use of other cleaning
and disinfecting processes, not specied by Respironics, may affect the performance of the product.
Symbol Key
The following symbols appear on the device:
Sy m b o l Defi ni ti on Sy m b o l Defi ni ti on
Maximum Fill Line Follow Instructions for Use
Hot Water, Hot Surface Drip Proof Equipment
3
System Features and Contents
IMPORTANT: Read and understand the entire manual for your therapy device before attempting to use this humidier.
Humidifier Door
Air Inlet Port
Air Outlet Port
Humidifier
(connects to Therapy Device)
Heater Plate
Water Ta nk
Maximum Fill Lines
This gure illustrates many of the device features and contents, described in the table below.
it e m De S c r i p t i o n
Humidier Connect your therapy device here.
Air Inlet Port Connects to the outlet port on the therapy device.
Air Outlet Port
(conical, 22 mm)
Connect the patient circuit here.
Heater Plate Warms the water in the water tank.
Humidier Door Open the door to access the water tank.
Humidier Door Lever Lift up on the lever to open the humidier door.
Water Tank The removable water tank holds the water for humidication.
Maximum Fill Lines The ll lines indicates the maximum water level for safe operation. (Found on front and both sides of tank)
Note: Read all instructions before using the humidier.
Note: This humidier is specied for use with Respironics REMstar and BiPAP therapy devices only.
4
Connecting the Therapy Device
1. When using a humidier, the patient circuit attaches to the air outlet port on the humidier.
2. To connect the therapy device to the humidier, rst you must remove the side cover on the therapy device. Press
in the tab on the side cover and pull the cover away from the unit.
Therapy Device
Side Cover
T a b
3. Next, line up the components side by side. Make sure that the guides on the humidier t into the slots on the
therapy device and the air outlet port on the therapy device ts into the air inlet port on the humidier.
T
herapy Device Humidier
Air Inlet Port
Air Outlet Port
Slots
Guides
4. Simply press the two units together until they snap into place. Make sure that the therapy device and the humidier
are completely seated against each other.
5
Disconnecting the Therapy Device
CAUTION: To avoid spilling, do not disconnect the humidier from the therapy device with water in the tank.
Remove the water tank from the humidier before disconnecting the therapy device.
1. Grasp the release latch on the bottom of the humidier.
2. While holding both the therapy device and the humidier, pull the release latch and pull the two units apart.
Release Latch
Humidifier
(bottom view)
Release Latch
3. If you will be using the therapy device without the humidier, reattach the side cover to the therapy device.
Daily Use
1. Place the connected therapy device with humidier on a rm, at surface lower than your sleeping position.
CAUTION: Do not place the humidier directly onto carpet, fabric, or other ammable materials.
CAUTION: Do not place the device in or on any container that can collect or hold water. Take precautions to
protect furniture from water damage.
CAUTION: Do not turn the humidier on without the water tank installed. The Humidier number setting must
remain on 0 if there is no water in the water tank.
CAUTION: Do not attempt to ll the tank while it is still inside the humidier.
WARNING: Allow the humidier heater plate and water to cool down for approximately 15 minutes before
removing the water tank. A burn may result from: touching the heater plate, coming in contact with the heated
water, or touching the tank pan.
2. Lift up on the release lever to open the humidier door until it locks in an open position. You will hear a “click”
once the door is opened far enough to remain in an open position. Remove the water tank by grasping the front of
the tank and sliding it out of the humidier base.
CAUTION: The humidier door must be set in the open position before removing the water tank. Do not
remove the water tank without making sure that the humidier door locks into the open position.
Cover Release Lever
Grasp the Water Ta nk
on top and bottom
6
3. Press the tab in the hole on top of the tank in toward the front of the tank. Gently remove the tank lid from the
tank base and set aside. Empty any remaining water from the base of the tank.
Middle Seal
Hinges
Ta b
Ta nk Base
Ta nk Lid
4. Rinse the tank with water. With the water tank sitting on a at surface, ll it with distilled water (approximately
325 ml) no higher than the maximum ll line located on the front and both sides of the tank.
Ta nk Base
Ta nk Lid
Maximum Water Fill Lines
CAUTION: Use only room temperature distilled water in the tank. Do not put any chemicals or additives into
the water. Possible airway irritation or damage to the water tank may result.
CAUTION: Do not ll the water tank above the maximum ll line. Damage to the humidier or therapy device
may occur. If the water tank is overlled, water may leak out of the tank inlet (located on the back of the tank)
when installing the tank lid.
7
5. Reassemble the tank by placing the hinges on the tank lid over the 2 tabs on the back of the tank base. Close the
lid until the tab on the lid snaps back under the lip in the tank base. Inspect the tank. When it is closed correctly,
the lid should be seated completely on the middle seal and it should sit snugly on the tank base so the tab can easily
snap back in place.
Middle Seal
Hinges
T a b
T a nk Base
T a nk Lid
Note: If the lid does not close easily onto the base, separate the two parts, reassemble the tank, and inspect it again.
CAUTION: Do not ll the water tank above the maximum ll line. Damage to the humidier or therapy device
may occur. If the water tank is overlled, water may leak out of the tank inlet (located on the back of the tank)
when installing the tank lid.
6. Slide the water tank back into the humidier.
WARNING: When installing the tank, do not allow any water to spill into the humidier or therapy device.
CAUTION: Do not move the humidier while the water tank has water in it.
7. Plug the power supply cord into the back of the therapy device.
8. Plug the AC power cord into the power supply provided with your therapy device, and then plug the AC power
cord into an electrical outlet that is not controlled by a wall switch.
9. Attach the exible tubing from the patient circuit to the humidier’s air outlet port.
IMPORTANT: Before each use, examine the exible tubing for any kinks, damage, or debris. If necessary, clean
the tubing to remove the debris. Replace any damaged tubing.
10. The Home screen (shown below) will appear on the therapy device.
Therapy
Info
Flex
Setup
Home Screen
Note: “Flex” shown above will display as the current Flex setting chosen by the provider.
11. Put on your mask assembly when the air starts to ow.
12. Turn the Wheel to toggle between the four options. Highlight “Therapy”. Press the Wheel to turn on the airow
and begin therapy. The Therapy screen will appear which will show the current pressure setting being delivered.
Note: For more information on your therapy device settings, refer to the manual included with your therapy
device.
8
13. The Humidier icon and current Humidier number setting will light up on the device.
Note: If you are having trouble with your mask, refer to the instructions included with the mask.
14. Turn the wheel to adjust the Humidier number to the desired heater plate setting. The settings are 0 (which
turns the heater plate off), 1, 2, 3, 4, and 5. The delivered Relative Humidity (RH) shall increase as the setting
increases.
CAUTION: Do not turn the humidier on without the water tank installed. The Humidier number setting must
remain on 0 if there is no water in the water tank.
IMPORTANT: The Humidier LED will remain on but will dim when the Humidier is attached. The number
may turn off depending on the LED Backlight settings.
IMPORTANT: The ideal humidity setting depends on room temperature and humidity. Initially a setting of 2 is
recommended. You can adjust this setting at any time. Turn the Wheel to change the setting.
Note: You can also adjust the humidier setting while therapy is off in the setup screen from the main menu.
15. Press the Wheel again to turn off therapy and return to the home screen.
9
Home Cleaning: Water Tank
WARNING: Before cleaning the humidier, always remove from the therapy device.
1. Turn the humidier setting to 0, turn the therapy device off, and allow the heater plate and water to cool.
WARNING: Allow the humidier heater plate and water to cool down for approximately 15 minutes before
removing the water tank. A burn may result from: touching the heater plate, coming in contact with the heated
water, or touching the tank pan.
2. Open the humidier door with the release lever, and then slide the water tank out of the humidier base.
3. Press the tab in the hole on top of the tank in toward the front of the tank. Gently remove the tank lid from the
tank base. Empty any remaining water from the base of the tank.
4. Wash the parts of the tank in a solution of warm water and a mild liquid dish detergent. Gently wash the middle
seal. Rinse the parts with clean water. Wipe the parts completely on the top and bottom. Allow them to air dry.
WARNING: Empty and clean the water tank daily to prevent mold and bacteria growth. Wipe the seal
completely.
5. Inspect the tank and seal for damage.
Note: Never use the water tank if the tank lid does not t comfortably on the tank base.
6. Before using the tank, ll it with distilled water (per the directions in the Daily Use section) no higher than the
maximum ll line located on the front and sides of the tank.
7. Reassemble the tank by placing the hinges on the tank lid over the 2 tabs on the back of the tank base. Close the
lid until the tab on the lid snaps back under the lip in the tank base. Inspect the tank. When it is closed correctly,
the lid should be seated completely on the middle seal and it should sit snugly on the tank base so the tab can
easily snap back in place. Inspect the water tank for any leaks or damage. If the water tank shows signs of wear or
damage, contact your home care provider for a replacement.
Note: If the lid does not close easily onto the base, separate the two parts, reassemble the tank, and inspect it again.
Home Cleaning: Humidier Base
1. Clean the humidier base and heater plate by wiping it with a damp cloth. Allow the platform to air dry before
reconnecting to the therapy device.
2. Inspect the humidier base for any damage and replace it if necessary.
3. Clean the humidier outlet port by using a damp bottle brush or a damp cloth. Insert the brush or cloth
approximately 7 cm (2.75 inches) into the outlet opening while cleaning.
10
Hospital and Institution Cleaning
CAUTION: Only the hospital and institution cleaning procedures listed in this manual are recommended
by Respironics. Use of other cleaning and disinfecting processes, not specied by Respironics, may affect the
performance of the product.
Cleaning Prior to Disinfection
Clean the humidier base and outlet as described in the previous Home Cleaning section.
Clean and disinfect the humidier’s water tank using the procedures below.
1. Disassemble the tank by separating the tank lid and tank base.
2. While soaking the tank pieces in mild liquid dish detergent, use a soft bristle brush to clean each piece. Pay close
attention to all corners and crevices.
3. Rinse each piece with water twice. Be sure to agitate it vigorously in water when rinsing and allow to air dry, but
not in direct sunlight.
Disinfection
The following processes can be used to disinfect the water tank for a maximum of 60 cycles:
• Thermal Disinfection: Immersion in a (tap) water bath at 75° C ± 2° C for 30 minutes
• Control III
• Cidex
• Cidex OPA
Following disinfection, visually inspect each piece. Discard and replace any damaged parts.
Service
The humidier does not require routine servicing. If any part of the humidier is worn or damaged, contact Respironics
or your home care provider. See the Troubleshooting section later in the manual for additional information.
Traveling with the System
Packing the System
1. Remove the water tank and empty all water.
2. Put the empty water tank back into the device.
3. Pack your humidier in your carry-on luggage.
CAUTION: Do not move the humidier while the water tank has water in it.
When you are traveling, the optional carrying case for your therapy device can be used for carry-on luggage only. The
carrying case will not protect the humidier if it is put through checked baggage.
For your convenience at airport security stations, there is a note on the bottom of the humidier stating that it is medical
equipment. It may be helpful to bring this manual along with you to help security personnel understand the device.
If you are traveling to a country with a line voltage different than the one you are currently using with the therapy
device, a different power cord or an international plug adapter may be required to make your power cord compatible
with those where you visit. Contact your home care provider for additional information.
11
Troubleshooting
The table below lists some of the problems you may experience with your humidier and possible solutions.
pr o b l e m Wh y it ha p p e n e D Wh a t t o Do
Nothing happens when
you apply power to the
humidier.
Loss of AC/DC power or
the device is unplugged.
Verify that the humidier and therapy device are properly plugged in.
Make sure the AC power cord is connected correctly to the power
supply and the power supply cord is correctly plugged into the wall.
If the problem continues to occur, contact your home care provider.
Return the humidier, therapy device, and power supply to your
provider to determine if the problem is with the therapy device,
humidier, or power supply.
High Leak The tubing is not
connected correctly and
doesn’t seal properly.
Remove your mask and tubing and check for kinks or tears. If it is
torn or damaged, contact your home care provider or Respironics
for replacement tubing and/or mask.
If the tubing is not damaged, reattach your tubing, turn on the
airow, and check to make sure you do not still feel air coming out
of the port area.
The therapy device is not
seated correctly against
the humidier.
Remove the therapy device from the humidier and reconnect. Make
sure the air inlet port on the humidier connects securely to the air
outlet port on the device.
If high leak persists, issue may be caused by a misaligned or damaged
seal. Seals are not user-serviceable components. Please contact your
home care provider or Respironics.
The humidier tank is not
properly seated in the
humidier.
Remove the water tank from the humidier base, and then slide the
tank back in the humidier, making sure it is pushed back as far as it
can go.
If high leak persists, issue may be caused by a misaligned or damaged
seal. Seals are not user-serviceable components. Please contact your
home care provider or Respironics.
The humidier LED icon on
the therapy device is ashing.
There is no communication
between the therapy
device and the humidier.
Following the Daily Use section earlier in this manual, check the
outlet power and verify that the humidier and therapy device are
properly plugged in. Make sure the AC power cord is connected
correctly to the therapy device’s power supply. Make sure the AC
power cord is correctly plugged into the wall.
If the problem continues to occur, contact your home care provider.
Return the humidier, therapy device, and power supply to your
provider, to determine if the problem is with the therapy device,
humidier, or power supply.
The therapy device is not
seated properly against the
humidier.
Remove the therapy device from the humidier and reconnect it.
Make sure the air inlet port on the side of the humidier connects
securely to the air outlet port on the side of the device.
The heater plate is not
heating.
Check the power connections to the humidier. If the problem
continues, contact your home care provider or Respironics.
Note: If the water is not heating, you can temporarily use the
humidier as an unheated pass-over humidier.
The humidier is cracked or
damaged.
The humidier was
dropped or mishandled.
If the humidier does not operate properly after being dropped or
mishandled, contact your home care provider or Respironics.
12
pr o b l e m Wh y it ha p p e n e D Wh a t t o Do
The therapy device is
operating but the humidier’s
airow is low or stopped.
The humidier has an
airow obstruction.
Contact your home care provider. Return the humidier and power
supply to your provider to determine the problem.
The water tank’s middle seal
is damaged.
The seal may become
damaged during use.
Check the seal for any tears or other damage. If it is damaged,
contact your home care provider.
Excessive condensation in
the tubing.
The heater plate
temperature setting is too
high.
Reduce the heater control setting.
The humidier is
positioned incorrectly.
Verify that the humidier and therapy device are away from air
conditioning equipment.
The humidier door has
been accidentally removed
from the humidier.
Humidier door was lifted
past the locked open
position.
The humidier door can be easily reattached.
With the water tank removed, align the hinge side of the door with
the back of the humidier in a fully open position (see gure below).
Make sure the hinges are aligned with the grooves of the humidier.
Rotate the door closed. You will need to apply pressure until the
door snaps past the locked open position. Verify that the door is
working properly.
If further assistance is needed, contact your home care provider.
The humidier has fallen off
your table or night stand.
The humidier may not
have been properly seated
on the night stand, or the
placement of the tubing
may have caused the device
to fall.
Always make sure your humidier is placed on a hard, at surface
so the rubber feet on the bottom of the humidier base can adhere
to the surface (make sure there is no fabric under the base). The
humidier must be level for proper operation.
Also, place the humidier away from the edge of the night stand or
table, so it doesn’t accidentally get knocked off the table.
If the humidier falls and water gets into the therapy device, drain all
water out of the therapy device. Allow it to air dry to make sure it is
completely dry before reapplying power.
If the placement of the tubing causes the humidier to fall, make sure
that you use proper hose management when setting up your device.
Route the tubing behind the bed’s headboard.
If the humidier does not operate correctly after falling, contact your
home care provider or Respironics.
Note: For information on troubleshooting your therapy device, see the manual included with your therapy device.
13
Specications
Environmental
Operating Temperature: 5° to 35° C (41° to 95° F)
Storage Temperature: -20° to 60° C (-4° F to 140° F)
Relative Humidity (operating & storage): 15 to 95% (non-condensing)
Atmospheric Pressure: 77 to 101 kPa (0 - 2286 m / 0 - 7500 ft)
Physical
Dimensions: 18 x 14 x 10 cm (7” L x 5.5” W x 4” H)
Weight: Approximately 0.89 kg (1.95 lbs.)
Water Capacity
325 ml (11 oz.) at recommended water level
Standards Compliance This device is designed to conform to the following standards:
IEC 60601-1 General Requirements for Safety of Medical Electrical Equipment
EN ISO 8185:2007 General Requirements for Humidication Systems
Electrical (When the heated humidier is used with a Respironics therapy device)
AC Power Consumption: 100 – 240 VAC, 50/60 Hz, 2.1 A
DC Power Consumption: 12 VDC, 5.0 A
Type of Protection Against Electric Shock: Class II Equipment
Degree of Protection Against Electric Shock: Type BF Applied Part
Degree of Protection against Ingress of Water: Drip Proof, IPX1
Mode of Operation: Continuous
Electromagnetic Compatibility: The device meets the requirements of EN 60601-1-2, 2nd edition.
Heater Plate
Max Temperature: 70° C (158° F)
Pressure Drop with Humidier
Max.: 0.3 cm H
2
O at 60 LPM ow
Humidity
Humidity
min
Output: 10 mg H
2
O/L
Measured @ max ow, 35° C, 15% RH.
14
Disposal
Dispose of this device in accordance with local regulations.
How to Contact Respironics
To have your device serviced, contact your home care provider. If you need to contact Respironics directly, call the
Customer Service department at 1-800-345-6443 or 1-724-387-4000.
You can also use the following address:
Respironics, Inc.
1001 Murry Ridge Lane
Murrysville, PA 15668
15
EMC Information
Because this heated humidier cannot operate without using a Respironics therapy device, refer to the device’s User
Manual for additional EMC information.
Gu i D a n c e a n D ma n u f a c t u r e r ’S De c l a r a t i o n - el e c t r o m a G n e t i c em i S S i o n S : This device is intended for use in the electromagnetic
environment specied below. The user of this device should make sure it is used in such an environment.
em i S S i o n S t e S t co m p l i a n c e el e c t r o m a G n e t i c en v i r o n m e n t - Gu i D a n c e
RF emissions
CISPR 11
Group 1 The device uses RF energy only for its internal function. Therefore, its RF
emissions are very low and are not likely to cause any interference in nearby
electronic equipment.
RF emissions
CISPR 11
Class B The device is suitable for use in all establishments, including domestic
establishments and those directly connected to the public low-voltage
power supply network.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage uctuations/Flicker emissions
IEC 61000-3-3
Complies
Gu i D a n c e a n D ma n u f a c t u r e r ’S De c l a r a t i o n - el e c t r o m a G n e t i c im m u n i t y : This device is intended for use in the electromagnetic
environment specied below. The user of this device should make sure it is used in such an environment.
im m u n i t y te S t iec 60601 te S t
le v e l
co m p l i a n c e le v e l el e c t r o m a G n e t i c en v i r o n m e n t -
Gu i D a n c e
Electrostatic Discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood, concrete or ceramic
tile. If oors are covered with synthetic material,
the relative humidity should be at least 30%.
Electrical Fast Transient/Burst
IEC 61000-4-4
±2 kV for power supply lines
±1 kV for input-output lines
±2 kV for supply mains
±1 kV for input/output lines
Mains power quality should be that of a typical
home or hospital environment.
Surge
IEC 61000-4-5
±1 kV Line to Line
±2 kV Line(s) to Ground
±1 kV differential mode
±2 kV for common mode
Mains power quality should be that of a typical
home or hospital environment.
Voltage dips, short
interruptions and voltage
variations on power supply
input lines
IEC 61000-4-11
<5% U
T
(>95% dip in U
T
) for 0.5
cycle
40% U
T
(60% dip in U
T
) for 5 cycles
70% U
T
(30% dip in U
T
) for 25 cycles
<5% U
T
(>95% dip in U
T
) for 5 sec
<5% U
T
(>95% dip in U
T
) for 0.5
cycle
40% U
T
(60% dip in U
T
) for 5 cycles
70% U
T
(30% dip in U
T
) for 25 cycles
<5% U
T
(>95% dip in U
T
) for 5 sec
Mains power quality should be that of a typical
home or hospital environment. If the user of
the device requires continued operation during
power mains interruptions, it is recommended
that the device be powered from an
uninterruptible power supply or a battery.
Power frequency (50/60 Hz)
magnetic eld
IEC 61000-4-8
3 A/m 3 A/m Power frequency magnetic elds should be at
levels characteristic of a typical location in a
typical hospital or home environment.
NOTE: U
T
is the a.c. mains voltage prior to application of the test level.
16
Gu i D a n c e a n D ma n u f a c t u r e r ’S De c l a r a t i o n - el e c t r o m a G n e t i c im m u n i t y : This device is intended for use in the electromagnetic
environment specied below. The user of this device should make sure it is used in such an environment.
im m u n i t y te S t iec 60601 te S t
le v e l
co m p l i a n c e
le v e l
el e c t r o m a G n e t i c en v i r o n m e n t - Gu i D a n c e
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz
3 Vrms
3 V/m
Portable and mobile RF communications equipment should be
used no closer to any part of the device, including cables, than the
recommended separation distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended separation distance:
d = 1.2 150 kHz to 80 MHz
d = 1.2 80 MHz to 800 MHz
d = 2.3 800 MHz to 2.5 GHz
Where P is the maximum output power rating of the transmitter in
watts (W) according to the transmitter manufacturer and d is the
recommended separation distance in meters (m).
Field strengths from xed RF transmitters, as determined by an
electromagnetic site survey a, should be less than the compliance
level in each frequency range b.
Interference may occur in the vicinity of equipment marked with the
following symbol:
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reection from structures,
objects, and people.
a: Field strengths from xed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM
and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to
xed RF transmitters, an electromagnetic site survey should be considered. If the measured eld strength in the location in which the device is
used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as re-orienting or relocating the device.
b: Over the frequency range 150 kHz to 80 MHz, the eld strengths should be less than 3 V/m.
Recommended Separation Distances between Portable and Mobile RF Communications Equipment and This Device: The device is
intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user
of this device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and this device as recommended below, according to the maximum output power of the
communications equipment.
ra t e D ma x i m u m po W e r
ou t p u t o f t r a n S m i t t e r
(W)
Se p a r a t i o n Di S t a n c e a c c o r D i n G t o fr e q u e n c y o f t r a n S m i t t e r (m)
150 kHz to 80 MHz
d = 1.2
80 MHz to 800 MHz
d = 1.2
800 MHz to 2.5 GHz
d = 2.3
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using
the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according
to the transmitter manufacturer.
Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reection from structures, objects,
and people.
Limited Warranty
Respironics, Inc. warrants that the system shall be free from defects of workmanship and materials and will perform in
accordance with the product specications for a period of two (2) years from the date of sale by Respironics, Inc. to
the dealer. If the product fails to perform in accordance with the product specications, Respironics, Inc. will repair
or replace – at its option – the defective material or part. Respironics, Inc. will pay customary freight charges from
Respironics, Inc. to the dealer location only. This warranty does not cover damage caused by accident, misuse, abuse,
alteration, and other defects not related to material or workmanship. The Respironics, Inc. Service department shall
examine any devices returned for service, and Respironics, Inc. reserves the right to charge an evaluation fee for any
returned device as to which no problem is found after investigation by Respironics, Inc. Service.
Respironics, Inc. disclaims all liability for economic loss, loss of prots, overhead, or consequential damages which
may be claimed to arise from any sale or use of this product. Some states do not allow the exclusion or limitation of
incidental or consequential damages, so the above limitation or exclusion may not apply to you.
This warranty is given in lieu of all other express warranties. In addition, any implied warranties – including any
warranty of merchantability or tness for the particular purpose – are limited to two years. Some states do not allow
limitations on how long an implied warranty lasts, so the above limitation may not apply to you. This warranty gives
you specic legal rights, and you may also have other rights which vary from state to state.
To exercise your rights under this warranty, contact your local authorized Respironics, Inc. dealer or contact
Respironics, Inc. at:
1001 Murry Ridge Lane
Murrysville, Pennsylvania 15668-8550
1-724-387-4000
1058288
1057395
JR 5/29/2009
EN-DOM
Manufactured for:
Respironics Inc.
1001 Murry Ridge Lane
Murrysville, PA 15668 USA
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Respironics System One Heated Humidifier User manual

Respironics
Brand
Respironics
Model
System One Heated Humidifier
Category
Humidifiers
Type
User manual
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